Ankylosing Spondylitis (AS) is a disease that represents a considerable economic burden to the health care system as well as the whole society. The introduction of biologic therapy, though allowing for superior clinical and work productivity outcomes, has significantly increased direct medical costs of AS. Therefore it is important to weight the benefits against the costs to gain a basis for decisions on health care resource allocation.

Due to differences in the health care systems, health insurance and general country settings, health economic data cannot be generalized across countries. Such data is generally lacking in Central and Eastern European countries, especially in the field of rheumatology. This study will evaluate selected health care resource utilization and productivity losses in patients with AS during and before the treatment with adalimumab in clinical practice. The impact of adalimumab therapy on the extent of outpatient attendance, hospitalizations and sick leave, which could be influenced by relatively short-term adalimumab therapy, will be taken into account, and in relation to treatment response. There is no published data on the impact of adalimumab therapy on hospitalizations and outpatient attendance in patients with AS. Further, data on health care resource utilization and sick leave before and during adalimumab therapy could be translated into financial cost estimates (potential cost savings) by each participating country, based on their own country specific cost per resource.

Percentage of patients who exhibit treatment response defined as ASDAS≥2.0 from baseline to month 3, 6, 9 and 12

Change in the Number of hospital inpatient days [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]

Difference in the number of hospital inpatient days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy

Change in the Number of hospitalizations [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]

Difference in the number of hospitalizations during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy

Change in the Number of sick leave days [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]

Difference in the number of sick leave days during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)

Change in the Number of sick leaves [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]

Difference in the number of sick leaves during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy (in employed subjects only)

Change in the Number of outpatient visits to each kind of health care provider: general practitioner, rheumatologist, other specialists, physiotherapist, rheumatology nurse [ Time Frame: From "Day 0 - 12 months" to "Day 0 + 12 months" ] [ Designated as safety issue: No ]

Difference in the number of outpatient visits to each kind of health care provider: general practitioner, rheumatologist, other specialists (ophthalmologist, gastroenterologist, dermatologist, physiatrist), physiotherapist, rheumatology nurse, during 12 months of adalimumab therapy and 12 months preceding the introduction of adalimumab therapy

This Post-marketing Observational Study (PMOS) will be conducted in a prospective, single-arm, multicenter, multi-country format.

Retrospective data will be obtained by medical chart or electronic record review.

According to the requirements for non-interventional or observational studies, no additional diagnostic or monitoring procedures will be applied to the patients included in the study other than those which would ordinarily be applied in the course of the particular therapeutic strategy. Only data which are part of routine will be collected.

As this is an observational, non-interventional study, patient's treatments are determined solely by the treating physician, which falls within the scope of the physician's/institution's general liability insurance coverage.

As this study is observational in nature, the follow-up visits are not interventional and strictly scheduled, but rather left to the judgment of each investigator. The investigator should record visit data in the case report form (CRF) from no more than five (5) visits, which are closest to the 3- month intervals within the 12-month study period for each patient. Failure to observe these usual practice intervals of patient visits will not constitute a breach or violation of the protocol.

No more than five (5) patient's visits are indicated for CRF completion within the 12-month observational period:

Visit 0 (V0): Baseline

Visit 1 (V1): Follow-up at 3 months

Visit 2 (V2): Follow-up at 6 months

Visit 3 (V3): Follow-up at 9 months

Visit 4 (V4): Follow-up at 12 months (Study End).

A patient may withdraw from this PMOS at any time without prejudice. If the physician, for any reason, decides it is in the best interest of the patient to permanently discontinue adalimumab, treatment should be stopped. The reason for discontinuation should be documented in the CRF

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Sampling Method:

Probability Sample

Study Population

This study is a post-marketing observational study (PMOS) in which adalimumab is prescribed in the usual manner in accordance with the terms of the local marketing authorization with regards to dose, population and indication.

Study population will consist of adult (aged ≥18 years) patients with ankylosing spondylitis (AS) that can be treated with adalimumab as per locally approved label and prescription guidelines.

Criteria

Inclusion Criteria:

Has ankylosing spondylitis (AS) and is eligible to start and/or continue adalimumab therapy according to the local product label and prescription guidelines,

Is adult (aged ≥ 18 years)

Has been started on adalimumab therapy no more than one (1) month prior to the study enrollment

Has negative result of tuberculosis screening test or is receiving tuberculosis prophylaxis as per local guidelines

Provided written Authorization to the investigator to use and/or disclose personal and/or health data, or Informed Consent if requested by the Local Regulations

Exclusion Criteria:

• Has contraindications for the treatment with adalimumab (please see the latest version of the locally approved label)

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754727